Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146678
• Other study ID #: BDR11578
• Secondary ID: 2010-019228-30U1
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2010
• Last updated: March 1, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug

Secondary Objectives:

• to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug

• to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix

Description:

The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of <1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) = 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.

Exclusion criteria:

• any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness

• More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months

• Frequent severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)

• Symptomatic hypotension, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position

• Presence or history of a drug allergy to clinically significant allergic disease

• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol

• Pregnant or breast feeding women

• Any medication within 14 days before inclusion, or within 5 times the elimination half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy, any vaccination within the last 28 days.

• Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab)

• History of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous
• Lixisenatide AVE0010
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Germany	Sanofi-Aventis Administrative Office	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma lixisenatide concentration curve (LIX-AUClast)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Primary	Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Area under the plasma lixisenatide concentration curve (AUC)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Time to Cmax (Tmax ) for lixisenatide		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Maximum smoothed body weight standardized glucose infusion rate GIRmax		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No
Secondary	Time to GIRmax (GIR-Tmax)		1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period	No